FISHER BRAND SUN-DEX GLUCOSE TOLERANCE BEVERAGE TG-30010P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-21 for FISHER BRAND SUN-DEX GLUCOSE TOLERANCE BEVERAGE TG-30010P manufactured by .

Event Text Entries

[16840484] I was given 10 fl oz of fisher brand sun-dex glucose tolerance test beverage to drink in 5 minutes. I told the lab person that it burned. She said, it sometimes does. As the morning wore on, the burning feeling continued to worsen from my mouth into my stomach. Then my mouth and tongue started itching. Approx 3 hrs after drinking the sun-dex, i called the dr and told his nurse what happened. They said, take benadryl and call back later. When i woke up, the burning felt worse, but the itching wasn't bad. I saw the dr. He also added protonix. Nothing helped the burning. Then in 1 to 2 days later, i called the dr back and they put me on nexium and maalox, which didn't help. The burning feeling is slowly going away. In 2008, i went back to the lab and told the tech what happened and i wanted to see the package for the drink. She gave me one of the bottles from the fridge so i can copy information from it. Dose or amount: 10 fluid ozs, frequency: once over 5 min, route: oral/047. Dates of use: one day in 2008. Diagnosis or reason for use: glucose tolerance test.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5005633
• MDR Report Key: 1002092
• Date Received: 2008-02-21
• Date of Report: 2008-02-11
• Date of Event: 2008-01-29
• Date Added to Maude: 2008-02-29
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FISHER BRAND SUN-DEX GLUCOSE TOLERANCE BEVERAGE
• Generic Name: NONE
• Product Code: MRV
• Date Received: 2008-02-21
• Catalog Number: TG-30010P
• Lot Number: UNK
• ID Number: UNK
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 971653

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2008-02-21